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510(k) Data Aggregation

    K Number
    K232486
    Device Name
    KARL STORZ Monopolar Resectoscopes with HF Cable
    Manufacturer
    Karl Storz SE & CO. KG
    Date Cleared
    2024-05-07

    (265 days)

    Product Code
    FJL, FAS, FBO, FDC, HIH
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K221893
    Device Name
    KARL STORZ Bipolar Resectoscopes with HF Cable
    Manufacturer
    KARL STORZ Endoscopy America, Inc
    Date Cleared
    2023-03-17

    (261 days)

    Product Code
    FJL, FAS, FDC, GEI, HIH
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures. The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic electrosurgical procedures. The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures. Indications for Use in UROLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures. Indications for Use in GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures Indications for Use in UROLOGY and GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
    Device Description
    Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in medical disciplines such as Urology and Gynecology. A resectoscope is a combined cystoscope (urology) or hysteroscope (gynecology) and electrosurgical instruments and consists of a sheath, obturator, working element and HF electrode.
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    K Number
    K230205
    Device Name
    Veloxion System
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2023-02-24

    (30 days)

    Product Code
    FJL, GEI, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
    Device Description
    The Veloxion System consists of the following components: - Veloxion Controller (with Integrated Fluid Control and video) - Footswitch - Veloxion Resectoscope - Veloxion Fluid Control Set - Veloxion Roll Stand The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes: - Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape - Tissue Catch: For collection of gross resected tissue pieces for pathology. The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.
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    K Number
    K191341
    Device Name
    Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2019-06-13

    (24 days)

    Product Code
    FJL, GEI, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.
    Device Description
    The Veloxion System consists of the following components: - Veloxion Controller (with Integrated Fluid Control) - Footswitch - Veloxion Resectoscope - Veloxion Fluid Control Set - Veloxion Video Control Unit - Veloxion Roll Stand The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes: - Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape - Tissue Catch: For collection of gross resected tissue pieces for pathology. - Waste Management Bags: To provide bags for final collection of outflow. The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit. The components of Veloxion System perform the following functions: - The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met. - The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps. - The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function. - The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user. - The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.
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    K Number
    K190099
    Device Name
    Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2019-03-15

    (52 days)

    Product Code
    FJL, GEI, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
    Device Description
    The Veloxion System consists of the following components: Veloxion Controller (with Integrated Fluid Control) with Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. The system also includes Class I accessories for handling waste: Waste Management Tubing and Tissue Catch. The system provides bipolar resection and coagulation of prostate adenomas, distends the cavity by filling with saline, and provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.
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    K Number
    K162979
    Device Name
    Veloxion System
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2017-03-24

    (149 days)

    Product Code
    FJL, GEI, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
    Device Description
    The Veloxion System consists of the following components: - Veloxion Controller (with Integrated Fluid Control) - o Footswitch - Veloxion Resecting Device Kit: ● - o Veloxion Resecting Device - o Sheath - 0 Continuous Flow Optical Obturator - Veloxion Fluid Control Set ● - Veloxion Saline Pole ● The Controller provides bipolar radiofrequency outputs (cut and coagulation) and fluid control through the use of two integrated peristaltic pumps. The Resecting Device is a disposable, hand held bipolar radiofrequency device configured for the resection and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps, in conjunction with the disposable Fluid Control Set, which provides continuous inflow and aspiration during the procedure.
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    K Number
    K102663
    Device Name
    AED RESECTOSCOPE
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    2010-12-30

    (106 days)

    Product Code
    FJL, FAS, FDC
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.
    Device Description
    Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of: - · Endoscope - · Resectoscope sheaths with obturators - · Working Element - · Electrodes The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use. The body contact materials are surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
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    K Number
    K062720
    Device Name
    S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    2007-03-22

    (191 days)

    Product Code
    FJL, FAS, FDC
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. For Urology: Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract. For Gynecology: Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation. Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.
    Device Description
    The bipolar S-line Resectoscopes with electrodes have a design similar to the traditional monopolar resectoscopes, but with an additional pin for the neutral pole at the working element. The HF bipolar connection cables have a standard resectoscope connector and in addition a neutral connection to the neutral pin at the neutral pin at the S-line working element and on unit side plugs for connection to bipolar generators.
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    K Number
    K042523
    Device Name
    RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    2005-03-18

    (182 days)

    Product Code
    FJL, HIH, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine polyps, intrauterine myomas or prostate adenomas via suction channel under continuous flow conditions following resection using a high-frequency electrode with a resectoscope.
    Device Description
    The Resection Pump 2228 is used in combination with a large diameter resectoscope to suction off tissue chips by a short pulse vacuum after the removal with a high-frequency electrode. The complete procedure is done under endoscopic view and continuous flow conditions. The airflow of the control tube is interrupted when the grip of the working element is in the end position and the tissue is cut. This results in a change in pressure which triggers the resection pump to open the tube clamp valve for a short period of time. This generates a brief vacuum pressure via the secretion trap and the tissue chip is sucked off and collected in the chip fluid trap. The resection pump 2228 is software controlled. Key functions and components are automatically monitored to ensure safe operation. If there is a fault, a message is shown on the LCD display in conjunction with an acoustic signal.
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    K Number
    K041610
    Device Name
    MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    2004-08-19

    (65 days)

    Product Code
    FJL, GEY, JCX
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Morce Scope Set 8970: The Morce Scope Set, in conjunction with a morcellation probe, and with its sheaths and obturators, is used in the cutting (morcellation) and continuous removal of large detached tissue masses. In combination with intracorporeal lithotriptors, e.g. operated pneumatically, by ultrasound, electro-hydraulically or by laser under endoscopic control, it can be used as a nephroscope in the disintegration and removal/aspiration of kidney and bladder stones and the removal of detached tumors from the bladder. Power Control 2303: The POWER CONTROL 2303 in conjunction with POWER STICK M4 serves to drive WOLF morcellators for the continuous removal of ablated tissue in endoscopic operations. Suction Pump 2207: The SUCTION PUMP is used for aspirating irrigation fluid in conjunction with a resectoscope or a morcellator following laser TURP. Indication and Field of Use: When used as a Morce Scope: for therapy via the transurethral passage after a TURP (TransUrethral Resection of the Prostate) procedure. When used as a nephroscope: for diagnosis and therapy of urolithiasis. In both cases the product must be used in conjunction with endoscopic accessories. The product may only be applied by adequately qualified and trained medical personnel.
    Device Description
    The Morce Scope Set 8970, is a morcellation set that consist of a Morce endoscope, rotary blade, sheaths, obturators and an optional sieve. The rotary blade is designed to be inserted through the Morce endoscope, requiring one incision. The rotary blades are driven by the motor on the Power Controlled by the Power Control Generator 2303. The suction pump 2207 removes the morcellated tissue.
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